drugset / Trial / NCT01342094

DE-111 Against Timolol Ophthalmic Solution 0.5%

NCT01342094 ↗

Phase 3 Completed 166 enrolled Santen Pharmaceutical Co., Ltd.
Parallel-groupTriple-blindTreatment

Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

Timeline

Start
2011-05
Primary completion
2012-09
Completion
—

Outcome

Met primary endpoint

registry analysis (superiority or other test); DE-111 vs Timolol; p < 0.001; Mean Difference (Final Values) -1.5 (95% CI -2.2 to -0.9); ANCOVA NCT01342094 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DE-111 Unknown — Other
Comparator Timolol Other / unclassified 0.5 % Other